Circulating Tumor Cells and mpMRI for Non-invasive Diagnosis of Prostate Cancer(CMNDPC)

Xi'an Jiaotong University

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Other: prostate cancer diagnosis

Study type: Interventional

Funder types: Other

Identifiers

NCT05947188

XJTU1AF2022LSL-010

Details and patient eligibility

About

This trial is a prospective, multicentre, diagnostic study. This study aims to evaluation the early diagnostic ability of circulating tumor cells plus multimodal MRI for prostate cancer.

Full description

This trial is a prospective, multicentre, diagnostic study. This study aims to evaluation the early diagnostic ability of circulating tumor cells plus multimodal MRI for prostate cancer.

We will enroll 808 men with clinical suspicion of prostate cancer due to higher level PSA（>4ng/ml）or other examination abnormal. All the participants will receive prostate biopsy，the circulating tumor cells（CTCs）will be detected before biopsy.

This study will evaluate the diagnostic ability of CTCs+MRI and CTCs+MRI+PSA，including sensitivity, specificity, predictive values, diagnostic accuracy and receiver operating curves（ROC）.

Enrollment: 808 estimated patients

Sex: Male

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. No family history of prostate cancer;
2. men ≥ 50 years；
3. tPSA level of 4-10 ng/ml, and fPSA/tPSA<0.16;
4. tPSA level of >10 ng/ml；
5. With abnomal mpMRI、PET/CT、TRUS or DRE;
6. fully understand the clinical trial protocol and sign the informed consent;

Exclusion criteria

1. Not meet all of the inclusion criteria or any single inclusion criteria；
2. previous diagnosis of prostate carcinoma ;
3. symptomatic of acute prostatitis;
4. local anesthetic allergy patients;
5. cannot tolerate prostate biopsy or has contraindication to biopsy;
6. patients judged by the investigator to be unsuitable to participate in the clinical trial;

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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808 participants in 1 patient group

Sample for Circulating Tumoral Cells

Experimental group

Description:

Sampling of Circulating Tumoral Cells will be done

Treatment:

Other: prostate cancer diagnosis